Gene-Modified Immune Cells for Melanoma and Solid Tumors
This study is looking at the safety and best dose of modified immune cells, called IL13Ralpha2 CAR T cells, for people with stage IIIC or IV melanoma or other solid tumors that have spread. These CAR T cells are made from your own white blood cells, grown in a lab, and changed to better fight cancer. Before receiving the CAR T cells, you will get chemotherapy drugs called cyclophosphamide and fludarabine phosphate. Researchers will measure side effects and how well the treatment works. This study is for adults aged 18 to 75 with specific types of advanced cancer. The current status of the study is unclear, and it plans to enroll 18 participants.
- Study design
- This is a dose-escalation study, meaning participants will receive increasing doses of IL13Ralpha2 CAR T cells to find the safest and most effective amount. It plans to enroll 18 participants.
- What's involved
- You would undergo a biopsy, blood draws, and CT scans. You would also receive cyclophosphamide and fludarabine phosphate intravenously (into a vein) before receiving the IL13Ralpha2 CAR T cells intravenously.
- Compensation
- Not stated in the trial record.
- Follow-up
- Researchers will monitor for adverse events (side effects) for up to 90 days after the CAR T cell infusion and for dose-limiting toxicity for up to 28 days.
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NCT04119024
Gene Modified Immune Cells After Conditioning Regimen for the Treatment of Stage IIIC or IV Melanoma or Metastatic Solid Tumors
Recruiting
PHASE1Ages 18–75InterventionalTreatmentAnusha KalbasiInvestigator-initiated
~18 participants
Updated 2026-03-17 on ClinicalTrials.gov
What's tested:BiopsyBiospecimen CollectionComputed TomographyCyclophosphamideFludarabine PhosphateFludeoxyglucose F-18
At a glance
Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events
Measured over Up to 90 days from the day of chimeric antigen receptor (CAR)-transgenic cell infusion
+1 more outcome measured
Conditions
Where it's being run
3 sites across 1 statesCalifornia3
Study leadership
- Allison Betof Warner, MD, PhD · PRINCIPAL_INVESTIGATOR · Stanford University
- Antoni Ribas, MD, PhD · PRINCIPAL_INVESTIGATOR · University of California, Los Angeles
- Yan Xing, MD, PhD · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Histologically confirmed malignancy that is considered surgically incurable with either:
Stage IIIC melanoma including locally relapsed, satellite, in-transit lesions or bulky draining node metastasis
Stage IV melanoma including patients with known brain metastases
Other metastatic, non-central nervous system (CNS) solid tumor relapsed or refractory after all standard-of-care systemic therapies for which the patient is eligible
Confirmed IL13Ralpha2 tumor expression by immunohistochemistry (immunohistochemical assay \[IHA\] H-Score \>= 50 in at least 10% of the total tumor specimen and in at least two high-power fields)
Age greater than or equal to 18 years old and less than 75 years old
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
A minimum of one measurable lesion defined as:
Meeting the criteria for measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST), OR
Skin lesion(s) selected as non-completely biopsied target lesion(s) that can be accurately measured and recorded by color photography with a ruler to document the size of the target lesion(s)
Absolute neutrophil count (ANC) \>= 1 x 10\^9 cells/L (determined within 30-60 days prior to enrollment; re-evaluated within 14 days of beginning conditioning chemotherapy)
Platelets \>= 75 x 10\^9/L (determined within 30-60 days prior to enrollment; re-evaluated within 14 days of beginning conditioning chemotherapy)
Hemoglobin \>= 9.5 g/dL (determined within 30-60 days prior to enrollment; re-evaluated within 14 days of beginning conditioning chemotherapy)
Aspartate and alanine aminotransferases (AST, ALT) =\< 2.5 x upper limit of normal (ULN) (determined within 30-60 days prior to enrollment; re-evaluated within 14 days of beginning conditioning chemotherapy)
Total bilirubin =\< 2 x ULN (except patients with documented Gilbert's syndrome) (determined within 30-60 days prior to enrollment; re-evaluated within 14 days of beginning conditioning chemotherapy)
Creatinine \< 2 mg/dL (or a glomerular filtration rate \> 45) (determined within 30-60 days prior to enrollment; re-evaluated within 14 days of beginning conditioning chemotherapy)
Patients with melanoma must have progressed following \>= 1 line of systemic therapy, including immune checkpoint inhibitor and a BRAF inhibitor in combination with MEK inhibitor for patients with BRAF V600-activating mutation and is not considered to have an alternate treatment option with curative intent
Must be willing and able to accept at least one leukapheresis procedure (This does not apply for patients receiving a second infusion of IL13R a2 CAR T cells as they will not undergo leukapheresis)
Must be willing and able to provide written informed consent
Exclusion
Inability to purify \>= 1 x 10\^7 T cells from leukapheresis product (this does not apply to patients receiving a second infusion of IL13Ra2 CAR T cells as they will not undergo leukapheresis)
Previously known hypersensitivity to any of the agents used in this study; known sensitivity to cyclophosphamide or fludarabine
Received systemic treatment for cancer, including immunotherapy, within 14 days prior to initiation of conditioning chemotherapy administration within this protocol
Clinically active brain metastases. Radiological documentation of absence of active brain metastases at screening is required for all patients. Prior evidence of brain metastasis successfully treated with surgery or radiation therapy will not be exclusion for participation as long as they are deemed under control at the time of study enrollment
Potential requirement for systemic corticosteroids or concurrent immunosuppressive drugs based on prior history or received systemic steroids within the last 2 weeks prior to enrollment; not including patients with primary or secondary adrenal insufficiency who require physiologic replacement with steroids, or patients on inhaled or topical steroids at standard doses
Human immunodeficiency virus (HIV) seropositivity or other congenital or acquired immune deficiency state, which would increase the risk of opportunistic infections and other complications during chemotherapy-induced lymphodepletion. If there is a positive result in the infectious disease testing that was not previously known, the patient will be referred to their primary physician and/or infectious disease specialist
Hepatitis B or C seropositivity with evidence of ongoing liver damage, which would increase the likelihood of hepatic toxicities from the chemotherapy conditioning regimen and supportive treatments. If there is a positive result in the infectious disease testing that was not previously known, the patient will be referred to their primary physician and/or infectious disease specialist
Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol
A Tiffeneau-Pinelli index \< 70% of the predicted value. Subjects will be excluded if pulmonary function tests indicate they have insufficient pulmonary capability
Patients will be excluded if they have a history of clinically significant electrocardiography (ECG) abnormalities, symptoms of cardiac ischemia or arrhythmias and have a left ventricular ejection fraction (LVEF) \< 45% on a cardiac stress test (stress thallium, stress multigated acquisition scan (MUGA), dobutamine echocardiogram, or other stress test)
Patients with ECG results of any conduction delays (PR interval \> 200 ms, corrected QT (QTC) \> 480 ms), sinus bradycardia (resting heart rate \< 50 beats per minute), sinus tachycardia (HR \> 120 beats per minute) will be evaluated by a cardiologist prior to starting the trial. Patients with any arrhythmias, including atrial fibrillation/atrial flutter, excessive ectopy (defined as \> 20 ventricular premature complex \[PVC\]s per minute), ventricular tachycardia, 3rd degree heart block will be excluded from the study unless cleared by a cardiologist
Pregnancy or breast-feeding. Female patients must be surgically sterile or be postmenopausal for two years, or must agree to use effective contraception during the period of treatment and for 6 months afterwards. All female patients with reproductive potential must have a negative pregnancy test (serum/urine) at screening and again within 14 days from starting the conditioning chemotherapy. The definition of effective contraception will be based on the judgment of the study investigators. Patients who are breastfeeding are not allowed on this study
A concomitant active malignancy that would be considered to interfere with the assessment of the primary or secondary endpoints of the study
What this trial measures
- Incidence of adverse eventsUp to 90 days from the day of chimeric antigen receptor (CAR)-transgenic cell infusion
Safety will be reported as incidence rates for adverse events, serious adverse events, and fatal adverse events for Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 3 or higher. Adverse events will be tabulated by treatment group and will include the number of patients for whom the event occurred, the rate of occurrence, and the severity and relationship to study drug.
- Dose-limiting toxicityUp to 28 days from the day of CAR-transgenic cell infusion